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Daniele Dionisio writes: Hopes that a comprehensive global health goal could be reached by 2035 are hardly credible with the load of unresolved issues still on the table. This article turns the spotlight on much-debated relevant questions that were left out or under-scrutinised in a recently published Lancet report.

Published online on 3 December, a Lancet Report developed a forward-looking investment agenda to attain dramatic health gains by 2035. The Report emphasises public revenue generation and public financing to be allocated to and within public health budgets especially for the poor populations in the low- and middle-income countries. And it asks for measures including, among others: full exemption of out-of-pocket expenses for the poor; poor-friendly pathways towards universal health coverage; heavy taxation on tobacco and other harmful substances; and reduction or elimination of energy subsidies on air-polluting fuels.

Apart from undeniable merits, including a statement of methodological caveats, the Report gives up on tackling a number of conflicting issues whose resolution is crucial to allow global health targets to be achieved by 2035. Regrettably, since these issues are far from settlement from a mid- to long-term perspective, the feasibility of the optimistic projections laid down in the Report remains doubtful.

These projections are unlikely to come off in today’s world landscape, which is torn by dis-alignment, litigations and frictions among the involved parties. This context entails that unbiased solutions for global health only hinge on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level.

Unfortunately, the world leaders are not ready to converge on this, and plenty of evidence shows that policy and trade directions, largely from the most advanced countries, run exactly contrary to these principles.

These directions and their impact on health were left out or under-scrutinised in the Lancet Report. This article seeks to spotlight some much-debated questions.

Intellectual Property Policies

The concerns above are appropriate now that trade agreements and governments’ choices, largely by the European Union (EU) and the United States (US), are turning intellectual property (IP) agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings.

In recent years, the EU has been pushing for exacerbated IP provisions in bilateral trade agreements with emerging economies such as India and Thailand. Meanwhile, a still underway US-led Trans-Pacific Partnership (TPP) deal has incurred criticism that without an infusion of standing power by TPP participating countries against US pressure, the US will force to consolidate monopoly control by big companies, hence undermining access to lifesaving medicines for millions of people in resource-constrained settings.

Relevantly, a June 2013 EU custom regulation has been blamed for allowing illicit seizing of in-transit goods (including legal generic medicines) “over a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit” and without “clear and convincing evidence of a substantial risk of diversion.” These terms run against EU commitments regarding access to treatments without restrictions.

These cases just represent the tip of the iceberg for the underhanded tactics to ensure that developing countries adopt IP clauses that go beyond the full extension they had a right to under the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).

These strategies add to the current breakthrough of multinational drug corporations in the middle-income country markets including through takeovers and buyouts of local companies.

TRIPS-plus measures would include: making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“evergreening”); restricting “pre-grant opposition,” which allows a patent to be challenged before it is being granted; enforcing intellectual property beyond what TRIPS requires; allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “in transit” products that are legal in origin and destination countries; expanding data exclusivity beyond WTO’s request for data protection against unfair commercial use only; extending patent lengths beyond 20-year TRIPS requirements; and preventing drug regulatory authorities from approving new drugs if they might infringe existing patents.

In the meantime, the government of Canada has killed a bill on access to medicines for developing countries. And there is more.

The impending threat of investor-state system enforcement as regards access to medicines cannot be underestimated. In this regard, many forms of government regulations, including price cuts of medicines, could be argued not to conflict with the TRIPS agreement, yet to make pointless or erode the expectations of the patent owners.

Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidise home manufacturing of the same medicine. A complaint against this country under an investor state system would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’ access to the market of medicines.

Under these circumstances, a claim could easily be lodged against a government for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

World Bank, WTO, IMF Programmes

Public opinion is increasing pressure against WTO and World Bank controversial economic reform programmes deemed to have a negative impact on health and health infrastructures in the developing countries. Pressure involves the International Monetary Fund (IMF) programmes that are charged with indirectly stifling health spending, while being too conservative about what policies are needed to attain macroeconomic stability in the borrowing countries.

This context has critically impaired access to food. Over the last 20-30 years, the World Bank and the IMF, and more recently the WTO, have forced countries to decrease investment in food production and to reduce support for peasant and small farmers. Under neo-liberal policies, state-managed food reserves have been considered too expensive and governments have failed to protect farmers and consumers against sudden price fluctuations, while being forced to “liberalise” their agricultural markets through reducing import duties and accepting imports for at least 5% of their internal consumption even if they did not need it. As such, the critics argue that the neo-liberal policies have destroyed the capacities of countries to feed themselves.

And this occurs at a time when land grabbing and evictions as part of neo-colonialism policies, including for biofuel agribusiness, are on the rise in Africa and elsewhere under national governments complacency and a widespread corruption.

This is the case with the EU, whose global plan for health development cooperation lacks coordination with the WHO, while the EU looks like it would disregard WHO as the most accountable actor, and a number of its political choices run contrary to the WHO directions. As an example, while the latest WHO and EU plans to address medicine quality issues have raised criticism of inadequate coordination and collaboration with each other, the Directive 2011/62/EU against falsified medicinal products did not mention WHO as a partner body for field purposes, and did not align with WHO definitions of Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products (or SSFFCs).

The poor legislative and regulatory framework monitoring the quality, sale and transit of medicines in the developing countries, coupled with the scarcity of human and financial resources and a lack of political will, have allowed the trade in counterfeit and substandard medicines to boom.

Estimates of counterfeit medicines sold in developing countries range from 10% to 30%, including treatments for malaria, tuberculosis and AIDS.

Substandard medicines are an even larger threat to public health than counterfeit ones, comprising at least half of tested medicines. The spread of these drugs is facilitated by the fact that for-export medicines to developing countries are often poorly regulated, with quality evaluation a mere formality and efficacy and safety testing not undertaken at all. Diversified production chains can exist within the same facilities: top quality for wealthy markets; intermediate for middle-income countries; and much lower quality for least-developed countries.

The importance of poor-quality medicines cannot be underestimated, as they may disrupt all major complex interventions to ensure treatment efficacy. Not only treatment failure may ensue, but emergence of drug resistances can be favoured.

Unfortunately, the legislation against counterfeit and substandard medicines too often does not address quality issues, but instead is aimed at protecting the commercial interests of brand-name drug manufacturers.

And now that new relevant initiatives risk overlapping, the governments are seemingly not ready for signing agreements whereby international donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organisations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorise export only of products meeting WHO quality, efficacy and safety standards.

“Brain Drain”, Health Worker Shortage

Scarce attention was paid by the Lancet Report to the critical shortage of health care professionals that limits the access to care to millions of individuals in resource-limited settings. This situation requires urgent action, such as a profound transformation of the present training approach, as to adapt curricula to local needs, promote strategies to retain expert faculty staff and reverse “brain drain”, expose trainees to community needs during training, promote multi-sector approach to education reforms, and strengthen links between the educational and health care delivery system. Western academic institutions’ role is to facilitate the process. The possible strategies for assistance should be in constant and balanced partnership.

Consensus Principles, Nothing Less

What expectations on these grounds? Hopes that a comprehensive global health goal could be reached by 2035 are hardly credible with the load of unresolved issues still on the table.

And the most advanced countries look like they wouldn’t be ready to embark on the gaps highlighted here as an opportunity for national security and profitable return on their disbursements rather than just a heavy burden in times of economic slump.

Yet, what shouldn’t be given up for this aim?

More money is obviously a key issue, but a coordinated, collaborative effort from all the parties is equally vital. Hence, a common agenda for shared health priorities is needed. And leading institutions and organisations must enhance working with health ministries to strengthen national systems, invest in infrastructures, improve transparency and accountability, and boost needs-driven rather than market-driven rules. This means giving up “closed doors” negotiations and adopting multi-sector participatory models for decisions affecting national health, growth, employment and budgets.

This entails linking together patent offices and legislators worldwide to develop evidence-based reforms of the patent regime of medicines. As reported“…[I]f countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the … market, new combination therapies, and lower … prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations….”

Eventually, global level institutions should work to increase coordination and effectiveness of the UN system. They should seek synergies with WHO to address global health challenges and support stronger leadership by the WHO to improve global health. They should enhance dialogue and joint action with key players, including UN agencies involved in global health, international financing institutions, regional organisations, regional health networks, and countries, in order to identify synergies, coordinate actions, advance in the achievement of commitments, and avoid overlapping and fragmentation.

Daniele Dionisiois a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is Head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio@tiscali.it https://twitter.com/DanieleDionisio

Comments

‘Evergreening’ again! Would the author like to explain why the patenting of new forms of medicines ‘ with no added therapeutic efficacy ‘ is so terrible? The old forms of the medicines are still available. If the new forms offer no advantage, why would anyone want to use them in preference to the old?

First, the ability to obtain patents on incremental, non-innovative changes may be detrimental to innovation of new therapies, rather than positive. It is well documented that companies regularly file incremental applications in order to extend the life of their existing patents and lengthen the effective patent term. This allows companies to retain market exclusivity without requiring them to innovate truly new medicines after their existing drug patents expire. Empirical evidence reveals that the rate of innovation has indeed started to slow down.

This market exclusivity permits companies to keep prices out of reach. For example, Ukraine is currently paying 10.13 times the lowest generic price for the pipeline HIV drug raltegravir, $6843 per person per year (pppy) versus $675 for the generic. Similarly, Argentina is paying 10.86 times the lowest generic price for the first-line drug atazanavir, $2912 pppy versus $268 pppy. These prices make it difficult or infeasible for governments to procure treatment for patients in low- and middle-income countries.

Second, the use of incremental patents as “blocking patents” can prevent the development of new technologies. In these cases, generic ART manufacturers are denied the ability to combine existing drugs into new combination therapies. This inability to produce new combinations generically is exacerbated by the refusal of many originators to voluntarily license their drugs to be used in combination therapies…”

Thanks for this reasoned response, and apologies for not coming back before. There is no doubt that the high price charged for patented drugs denies access to many people who would benefit from them. However, high prices are needed to finance the research that produces the drugs. Without them the drugs would not exist, and nobody would have access to them. Or so the argument runs. It may or may not be valid (I believe it is) but it applies against all drug patents, not just those on incremental improvements. I do not see that the paper quoted answers my original question. The strongest argument made is the popularity of such patents – undoubtedly pharmaceutical manufacturers see value in them, or they wouldn’t file so many. But this doesn’t prove that they have the effect claimed. The point remains, that if the advances claimed are trivial, there is no need for competitors to adopt them. Given the price differences between generic and patented drugs, a small difference in efficacy or efficiency would hardly outweigh a major reduction in price. Why do the generic manufacturers need to be able to copy a current drug formulation in every detail?